Quality Associate

1 week ago

Box Hill North, Victoria, Australia Planet Innovation Full time

Planet Innovation (PI) is an award winning healthtech contract design and manufacturing company and we work on some of the most advanced technology in the world.

We have our own portfolio of businesses, and also partner with world-leading organizations to help them create game-changing innovations to grow their business.

Our clients include some of the world's top medical device and healthcare companies, as well as some of the world's most exciting start-ups.

Creating great products and winning awards is all down to our team.

Planet Innovation has over 400 of the brightest and most passionate people on Earth, and we are looking for more.


As part of our continuous growth, we are looking for a Quality Associate to join our Quality team working on product design and development.


The Role


The Quality Assurance/ Regulatory Specialist assists the Quality Assurance and Regulatory team to manage the company's overall Quality and Regulatory Management Systems such as ISO134585, 21 CFR part 820, EU 2017/745 (MDR) EU 2017/746 (IVDR) and various other country specific regulations.

You will be responsible to provide Quality Assurance support at various stages of Product Design and Development, together with the responsibility for "on the floor" implementation of quality assurance procedures and processes as well as assisting the broader PI team with respect to compliance.


The Accountabilities:

  • Responsible for supporting Design Quality Assurance activities in Product Development and Life Cycle processes including design controls, quality planning, risk assessments/analysis/management, design reviews, approval of test methods, design and process verification and validation test plans and reports
  • Supporting the PI Design/ Digital team with design changes and play an important role in reviewing and approving design changes and in developing/ improving riskbased product controls
  • Review and approve product and process qualification and validation and other change control related documentation
  • Lead and be responsible for evaluating, investigation and closure of Quality Management System activities such as Non-Conformance, CAPA and Customer complaints
  • Perform Quality Management System Activities (Internal/ External Supplier audits, support manufacturing team on need basis, Design Transfer activities, Change Control)
  • Participate and represent QA/RA in technical review and formal design review meeting with internal and external stakeholders.
  • Prepare and maintain key Quality Objective KPIs for the Quality Management Systems
  • Act as an effective team member in the execution of Quality functions in compliance with FDA QSRs, EU MDR/IVDR (Design Control, CAPA, etc.), ISO 13485 and other national and international quality and regulatory requirements and standards
  • Generate internal quality documentation such as Quality plans, Quality procedures and Work Instructions
  • Track quality trends and initiate action items to resolve issues. Manage assigned corrective actions
  • Mentor and provide training assistance to QA Associate's
  • Provide training, awareness and support for quality system processes and quality engineering practices to PI wider team

The Typical Experiences:

  • Minimum 5 to 7 years Quality/ Regulatory and experience within the medical device industry
  • Exposure to medical (ISO auditor experience
  • Previous Quality and Regulatory experience in the medical device industry or equivalent is a must
  • A team player and selfstarter who will work side by side with the development team
  • Demonstrated ability to plan and priorities
  • High degree of independence in approach
  • Ability to multitask, prioritize tasks and quickly adjust in a rapidly changing environment
  • Excellent verbal and written communication skills
  • Thorough working knowledge and experience in medical device standards such as ISO 13485, ISO 14971, IEC 62304 and IEC 62366 etc.

Flexible Ways of Working
We are proud to be an equal opportunity employer.

We are committed to creating an inclusive environment for all employees, and all suitably qualified applicants will receive consideration for employment without regard for race, gender, sexual orientation, religion, disability, or age.

No recruitment agencies, please.

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